Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries: Randomized double-blind study

Figures & data

Figure 1. concort flow chart of the study groups.

Table 1. Demographic and clinical data of the studied groups.

Variable	Group B (n = 40)	Group N (n = 40)	P-value
Age/years	4.75 ± .5	4.60 ± .4	= 0.807^a
Sex			= 0.431^b
Male	32 (80%)	29 (72.5%)
Female	8 (20%)	11 (27.5%)
Anthropometric Measures
Weight/kg	16.90 ± 6.3	16.28 ± 6.1	= 0.653^a
Height (cm)	104.05 ± 15.2	103.73 ± 12.4	= 0.917^a
BMI	15.08 ± 1.7	14.57 ± 1.6	= 0.182^a
ASA
ASA-I	37 (92.5%)	39 (97.5%)	= 0.308^c
ASA-II	3 (7.5%)	1 (2.5%)
Type of Operation			= 0.897^d
Hernia	13 (32.5%)	5 (12.5%)
TA Pull-through	4 (10%)	23 (57.5%)
Hypospadias	23 (57.5%)	8 (20%)
Undescended Testis	0 (0%)	4 (10%)
Duration of Anesthesia/minutes
	87.01 ± 14.6	82.38 ± 1.9	=.464^a
Duration of Operation/minutes
	75.73 ± 15.1	7.75 ± 13.9	=.444^a

Data were presented as mean ± SD, number of patients, and percentages.

p value < 0.05 was considered as significant.

^aIndependent t-test was used to compare differences in means between groups.

^bChi-square test was used to compare differences in frequency between groups.

^cFisher’s exact test was used to compare differences in frequency between groups.

^dMonte Carlo exact test was used to compare differences in frequency between groups.

Table 2. Postoperative PAED agitation scale comparisons between groups.

		Group B (n = 40)	Group N (n = 40)	P-value
PAED Agitation Scale Score
Baseline		9.58 ± 1.1	9.45 ± .9	=.582 a
30-min		5.48 ± .5	5.60 ± .5	= 0.268^a
60-min		1.50 ± .5	1.53 ± .5	= 0.826^a
120-min		.03 ± .2	.01 ± .01	= 0.320^a
P-value^b		<.001	<.001	P = 0.595^c
PAED Category
Baseline	° No	22 (55%)	22 (55%)
	° Agitated	13 (32.5%)	16 (40%)	= 0.450^d
	° Severe	5 (12.5%)	2 (5%)
30-min.	° No	40 (100%)	40 (100%)	NA
60-min.	° No	40 (100%)	40 (100%)
120-min.	° No	40 (100%)	40 (100%)

Data were presented as number of patients and percentage.

P values < 0.05 was considered as significant. NA=Not Applicable.

^aMean differences between Group Comparison.

^bMean differences within Group Comparison.

^cTwo-way Repeated Measure ANOVA was used to compare the mean differences over time.

^dChi-square analysis was used to compare the frequency among groups.

Table 3. Comparison of postoperative RASS score between study groups.

RASS Score	Group B (n = 40)	Group N (n = 40)	P-value^a
Baseline	−2.43 ± .5	−3.15 ± .8	<.001
30-min.	−.40 ± .1	−.78 ± .4	<.001
60-min.	0 ± 0	0 ± 0	NA
120-min.	0 ± 0	0 ± 0	NA
P-value^b	<.001	<.001	P < 0.001^c

Data were presented as mean ± SD. P values < 0.05 was considered as significant.

^aMean differences between Group Comparison.

^bMean differences within Group Comparison.

^cTwo-way Repeated Measure ANOVA was used to compare the mean differences over time.

Table 4. Comparison of postoperative m-CHEOPS score between groups.

m-CHEOPS Score	Group B (n = 40)	Group N (n = 40)	P-value^a
Baseline	.45 ± .1	.35 ± .1	=.368
30-min.	1.40 ± .5	1.08 ± .4	=.022
60-min.	2.75 ± .7	2.40 ± .5	=.015
120-min.	3.33 ± .5	3.33 ± .5	= 1.000
6 hours	5.08 ± .9	3.63 ± .5	<.001
12 hours	4.43 ± .5	5.08 ± .8	<.001
18 hours	4.18 ± .5	4.18 ± .5	= 1.000
24 hours	3.90 ± .4	4.00 ± .3	=.251
P-value^b	<.001	<.001	P = 0.027^c

Data were presented as mean ± SD. P values < 0.05 was considered as significant.

^aMean differences between Group Comparison.

^bMean differences within Group Comparison.

^cTwo-way Repeated Measure ANOVA was used to compare the mean differences over time.

Table 5. Distribution of study groups according to postoperative outcomes.

Variables	Group B (n = 40)	Group N (n = 40)	P-value
Time to Recovery/min	8.98 ± 1.1	9.23 ± 1.2	= 0.340^a
Time to 1st Analgesia/h
Mean ± SD	7.08 ± 1.3	11.00 ± .8	<0.001^b
Median (Range)	7 [6] - [12]	11 [10] - [12]
Total Analgesic Dose – paracetamol (mg)
Mean ± SD	625.01 ± 333.7	432.92 ± 225.3	= 0.020^c
Median (Range)	495 (210–1300)	390 (165–1125)
Parents’ Satisfaction
V. Satisfied	19 (47.5%)	28 (70%)
Satisfied	19 (47.5%)	10 (25%)	= 0.097^a
Neutral	2 (5%)	2 (5%)

Data were presented as mean ± SD, number of patients, and percentages.

p value < 0.05 was considered as significant.

^aChi-square test was used to compare differences in frequency between groups.

^bIndependent t-test was used to compare differences in means between groups.

^cMann Whitney U test was used to compare Median between groups.